Mary McGann, MPH, MSW

As the appointed Research Coordinator at Bastyr University's Research Institute, I was assigned the task of collaborating with colleagues at the University of Washington, University of California, Los Angeles, and what is now the AVT Institute for Advanced Research in Tamil Nadu, India, to develop a two-phase international research grant application.

The successful application was funded by the National Institutes of Health to create an international research center in Tamil Nadu, assemble and train a research team to collaborate with their US counterparts at the aforementioned universities, and conduct a randomized clinical trial of Methotrexate and Classical Ayurvedic Medicine in the Treatment of Rheumatoid Arthritis according to US FDA standards. This study was awarded the 2012 European Society for Integrative Medicine's "Excellence in Integrative Medicine Clinical Research Award."

In year 3 of the project, I managed the successful transition of the primary study location from Bastyr University to the University of Washington, and then to the AVT Institute for Advanced Research for the remaining years of project. We continue to conduct clinical trials in complimentary medicine at our Coimbatore location as well as multiple trial sites throughout India.

During the first clinical trial and several trials since that time, I have performed the following duties:

⦁ Assessed foreign institution's IT research infrastructure, recommended, and advocated for necessary upgrades, and led IT and data teams based in India;
⦁ Collaborated in the design, implementation, and remote daily management of the protocol for the: Double-blind, Randomized, Double-dummy, Placebo Controlled Trial of Methotrexate, Complete Ayurveda, or the Combination in the Treatment of Rheumatoid Arthritis;
Assisted in preparation of IRB application, informed consent document, and provided monitoring and reporting services and support;
⦁ Developed job descriptions and provided input regarding hiring and dismissal decisions;
⦁ Delivered training in Good Clinical Practices for Clinical Trials (GCP) and Good Clinical Data Management Practices (GCDMP);
⦁ Created study Case Report Forms (CRFs) to gather patient based outcomes, and medication and laboratory data, research study documents, and Standard Operating Procedures (SOPs)for data collection and cleaning;
⦁ Delivered training in, and monitoring of, the recruitment, screening, interviewing, and retention of research participants;
⦁ Established and conducted data quality assurance (QA) activities including query resolution and reporting services;
⦁ Created clinical trial site monitoring documents, provided assistance with site monitoring, and managed source and regulatory documents;
⦁ Designed, implemented, and managed study databases, data dictionaries, data analysis sets, and analysis requests; and
⦁ Prepared and executed statistical analysis plan, as well as analysis of safety data for regulatory reports.

In this contract funded position, I coordinated or managed several large clinical and health outcomes studies and epidemiological research projects, including: An Analysis of the Relationship between Myocardial Infarction, HIV, and Antiretroviral Therapy; Health Care Utilization and Clinical Outcomes Among HIV Infected Adults; HIV Retention in Care; HIV and Malignancy Trends; the Center for AIDS Research Clinical Network of Integrated Clinical Systems (Hopkins site); the North American AIDS Cohort Collaboration on Research and Design of the International Epidemiological Databases to Evaluate AIDS (Hopkins site); and the HIV Research Network (Hopkins site)

Specific tasks for which I was responsible include:

• Designing, implementing, and leading clinical, health services, patient outcomes, and epidemiological research projects and program efforts;
• Conducted subject visits from screening through final study visit including administering informed consent process, and reporting and documenting safety issues;
• Assigning, training, overseeing, and evaluating tasks performed by on- and off-site Clinical Research Coordinators and other study team members;
  ⦁ Developing and managing multidimensional databases containing claims, pharmacy, and outcomes data, as well as analyzing and reporting on the data;
  ⦁ Developing data collection tools such as surveys, chart abstraction forms, CRF and associated protocols, project plans, data management and analysis plans, informed consent documents, and participating in the preparation of IRB applications and reports;
  ⦁ Providing data management of several complex, longitudinal studies with oversight of IT staff involved in the projects;
  ⦁ Creating, or participating in the development of, recruitment and retention plans, including training in and monitoring of recruitment process;
  ⦁ Attending and contributing to Investigator meetings, site visits, and clinical conferences;
  ⦁ Designing and implementing systems for monitoring, reporting, and quality assurance activities for on- and off-site health, clinical, outcomes, and epidemiological studies;
  ⦁ Ensuring program quality, research fidelity, and adherence to goals and timelines;
  ⦁ Conducting statistical analyses of pharmacy, cost, laboratory, and health outcomes data, and preparing reports;
  ⦁ Participating in the development of new and continuation project grant applications;
  ⦁ Working closely with study team to ensure adherence to regulatory requirements;
  ⦁ Directing data managers in developing and making database enhancements, queries, and reports;
  ⦁ Developing budgets with PI and CoPIs in addition to monitoring budget expenditures; and
  ⦁ Making strategic recommendations/decisions to meet project goals.

Managed the following healthcare and economics outcome projects from design through completion for federal, state, and local governments, as well as payer, private and nonprofit organizations: Medicare Payment Advisory Commission ( MedPAC) Health Care Quality and Payment Study; Operational Research for Home Healthcare and Hospice State Licensing Agencies, Professional Associations, and Providers; Negative Pressure Wound Therapy; Quality of Care and Financial Indicators for Hospice and Home Health Agencies; and Wound Care Data Repository Development and Research.

Specific responsibilities I executed in the management of these projects include:

• Retrospective cross sectional and longitudinal analysis of large federal, state, and local government, and provider claims, pharmacy, and health and clinical outcomes datasets (>2 million CMS records);
• Developing and managing of grant applications, budgets, industry contracts, subcontracts, and project plans and task lists;
• Analyzing data in various formats and preparing reports of healthcare finance, utilization, outcomes, and policy changes;
• Conducting quality of care, process improvement, and cost-effectiveness studies;
• Developing quality of care indices and performing psychometric testing;
  Assisting state home health and hospice associations in quality improvement project planning, data collection and submission, report interpretation, implementation, and monitoring;
• Preparing IRB applications, exemption requests, and progress reports;
  Directing and coordinating diverse, cross departmental, and inter-organizational project teams ranging in size from 3 to 12 members;
  Database development and management, including QA activities, query resolutions, and reporting services;
• Leading work group in the development and implementation of project management, data management, and QA SOPs;
• Creating and testing data collection tools, training staff to perform data collection and cleaning, and monitoring adherence to data collection protocols and data quality;
• Patient recruitment plan development and training for multiple study sites;
• Developing and executing statistical analysis plans, and training staff in statistical methods and software; and
• Authoring literature reviews, reports, manuscripts, and preparing and delivering presentations

Coordinated the following clinical research studies and provided database development/management, and statistical analysis for the Clinical Trials of: Echinacea for Upper Respiratory Tract Infections, St. John’s Wort for ADHD and Depression; Milk Thistle for Juvenile Arthritis; Complementary and Alternative Medicine End of Life Therapy; Silymarin for Chronic Hepatitis C; Allium sativum for Hyperlipidemia Induced by HAART in HIV-Positive Individuals; and Telehealth Delivery of Weight Loss Program for Diabetics.

Responsible for database development/management and statistical analysis for two laboratory projects: Cytotoxic Effect of Oyster Mushroom Pleurotus ostreatus on Human Androgen-Independent Prostate Cancer PC-3 Cells, and Quality Assurance of Lactobacillus-containing Dietary Supplements Commercially Available in Washington State.

Co-authored two National Institutes of Health Developmental Center grant applications: Planning Grant for Development of International Center for CAM Research on Ayurvedic Medicine, and the Developmental Center for Research on CAM to study Trametes Versicolor-Induced Immunopotentation.

My primary duties as the Research Coordinator and Data Manager/Analyst for these projects and programs were:

• Designing and utilizing data collection tools (e.g., surveys, CRFs and chart abstraction forms-electronic and paper-based), usability tests, and focus group scripts;
• Managing the recruitment, enrollment and retention of research participants including conducting Informed Consent process;
• Conducting research participant clinical visits from screening through study completion, including human specimen/sample collection, monitoring medical status, reporting and documenting adverse events; and administering questionnaires and assessments according to the study protocol;
• Preparing grant application and budgets;
• Creating data analysis plans, code books, analytical datasets, and conducting statistical analyses;
• Performing data collection, data requests, query resolution, and report preparation;
• Guest lecturing on research methods and clinical trials for undergraduate and graduate level courses;
• Developing SOPs, subject recruitment plans, study binders, and IRB applications and reports;
• Initiating, monitoring, conducting study site start-up, and preparing for and participating in audits and close-out visits ;
• Compiling and maintaining regulatory files and binders, source documents, and drug accountability records;
• Hiring, supervising, and training graduate student assistants, research interviewers, and support staff;
• Mentoring pre-post-doctoral fellows in grant writing, IRB application development and reporting, budgeting, study design and methodology, and data management/analysis;
• Co-scripting, directing, recording, and co-editing intervention educational videos, and co-authoring manuscripts for publication;
• Administered Faculty Seed Grant and External Research Programs; and
• Served on Research Steering Committee and IRB Team B.